A Prospective Investigator-initiated Study for dose-finding of lenalidomide in Multiple Myeloma (MM) Patients with Impaired Renal Functio

Not Applicable

• Conditions: Neoplasms

• Registration Number: KCT0008994
• Lead Sponsor: The Catholic University of Korea, Seoul St. Mary's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Eligibility Criteria (All of the following must be met):
1)Male or female aged 19 to less than 72 years
2)Patients with multiple myeloma according to the IMWG criteria (see 19. Other Necessary Matters for Safe and Scientific Clinical Research for reference)
3)Patients diagnosed with multiple myeloma meeting the following criteria (all of the following must be met):
Monoclonal plasma cells in the bone marrow
=10% or confirmed plasmacytoma by tissue examination
Patients with evaluable multiple myeloma and one or more of the following:
i. Serum M-protein = 0.5 g/dL or urine M-protein = 200 mg/24 hours
ii. IgA multiple myeloma: Serum M-protein = 0.5 g/dL or urine M-protein = 200 mg/24 hours
iii. Light chain multiple myeloma: Serum free light chain (sFLC) = 100 mg/L and abnormal serum kappa/lambda free light chain ratio
4)Patients who are intended to receive lenalidomide maintenance therapy* as the first-line treatment following autologous hematopoietic stem cell transplantation and who have not received lenalidomide treatment previously
*Lenalidomide maintenance therapy is defined as the use for long-term disease control purposes without evidence of disease progression of multiple myeloma within 180 days from the autologous hematopoietic stem cell transplantation
The criterion for the autologous hematopoietic stem cell transplantation is defined as the first autologous stem cell transplantation if it is terminated once, and as the second autologous stem cell transplantation if it is performed twice consecutively (Tandem autologous stem cell transplantation)
This selection criterion is identical to the criteria for health insurance application in the current medical field in Korea
5)Renal dysfunction: eGFR < 60 mL/min
6)Patients with appropriate liver function (both of the following must be met)
Serum total bilirubin less than twice the upper limit of normal (however, less than three times the upper limit of normal in cases of Gilbert's syndrome)
AST/ALT less than 2.5 times the upper limit of normal
7)Overall performance status (Eastern Cooperative Oncology Group Performance Status) 0-2
8)Normal cardiac function (Ejection fraction = 45%)
9)Appropriate marrow function (all of the following must be met)
Neutrophil count = 1,000/µL
Platelet count = 70,000/µL
Hemoglobin = 9 g/dL
10)For female subjects,
Period of amenorrhea for 1 year or more (postmenopausal women), or
Negative pregnancy test before the start of treatment (screening) and able to maintain contraception during the study participation period for women [applies to premenopausal women or women with a period of amenorrhea of less than 1 year (within 1 year after menopause)]
*During the consent process for fertile women, the subject is informed about natural cycle methods, abstinence, and other contraceptive methods according to the Catholic ideology of the institution.

Exclusion Criteria

Exclusion criteria are as follows
1)Asymptomatic multiple myeloma (smoldering multiple myeloma), active plasma cell leukemia, monoclonal gammopathy of undetermined significance (MGUS), amyloidosis, or multiple myeloma involving the central nervous system
2)Active cardiovascular dysfunction
3)HIV positive
4)Active hepatitis A, B, or C
5)Patients with cancers other than multiple myeloma currently undergoing or in need of treatment
6)Patients with a history of other cancers, excluding cured non-melanoma skin cancer and in situ carcinoma of the cervix within the past 5 years
7)Peripheral neuropathy of grade 3 or higher or peripheral neuropathy with pain of grade 2 or higher
8)Participation in another clinical study involving the administration of anti-neoplastic agents within the last 3 weeks
9)Platelet or red blood cell transfusion within 14 days of Cycle 1 Day 1
10)Administration of hematopoietic growth factors such as G-CSF, GM-CSF, erythropoietin, or megakaryocyte growth factor within 14 days of Cycle 1 Day 1
11)Concurrent severe psychiatric illness making the patient unable to participate in the study
12)Pregnant women

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The time to reach maximum plasma concentration (Tmax) from administration of lenalidomide

Secondary Outcome Measures

Name	Time	Method
The area under the curve (AUC0-24) until the final sampling time.; The elimination rate constant (?z).; The final half-life (t1/2) calculated from ?z.;Oral clearance (CL/F) and volume of distribution (V/F) calculated from the area under the curve.